Can-Fite shares plunge after investigational psoriasis therapy CF101 fails to meet primary goal in Phase II/III study

Shares in Can-Fite BioPharma declined more than 60 percent Monday after the experimental drug CF101 did not meet its primary endpoint in a Phase II/III study of patients with moderate-to-severe plaque psoriasis. Topline results indicated that the therapy was not associated with significant improvement in symptom severity, versus placebo.

In the study, 326 patients with moderate-to-severe plaque psoriasis were randomised to one of two doses of CF101 or placebo, with all patients in the placebo arm switched to CF101 after 12 weeks and continuing on the treatment until week 24. Can-Fite stated that after a positive interim analysis, it continued to enroll patients to the second segment of the study, which was comprised of two arms with 223 patients receiving either the higher dose of CF101 or placebo. All patients receiving placebo were switched to CF101 after 16 weeks and continued receiving treatment until week 32. In addition to the primary endpoint, secondary objectives included the Physicians' Global Assessment (PGA) score and various safety parameters.

Results at 12 weeks demonstrated that the proportion of patients who achieved at least a 75-percent improvement in disease severity as measured by the Psoriasis Area Sensitivity Index was 8.5 percent for the CF101 group, versus 6.9 percent in the placebo group. Regarding PGA, the proportion of patients who achieved clear or almost clear skin at week 12 was 6.4 percent for CF101-treated patients, compared to 3.4 percent in the placebo group, which was also not significant. The company noted that CF101 was found to be safe and well tolerated.

Can-Fite CEO Pnina Fishman said the company was "disappointed that our trial did not meet its primary endpoint," but cautioned that "we have not yet completed our analysis of secondary endpoint and sub-group analysis and intend to complete it in the near future."

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